The field of interventional psychiatry reached a historic moment in late 2025 when the U.S. Food and Drug Administration approved the first at-home brain stimulation device for the treatment of major depressive disorder in adults. Developed by Flow Neuroscience, the FL-100 device introduces a new way to deliver noninvasive neuromodulation outside of traditional clinical settings.
This approval reflects growing interest in expanding access to brain-based treatments, especially for patients who do not respond well to standard antidepressant medications or who experience unwanted side effects. At-home brain stimulation for depression may help bridge the gap between medication, psychotherapy, and clinic-based neuromodulation approaches such as transcranial magnetic stimulation.
How The FL-100 Device Works
The FL-100 is a wearable headset that delivers transcranial direct current stimulation, commonly referred to as tDCS, to the dorsolateral prefrontal cortex. This brain region is closely linked to mood regulation, emotional control, and executive functioning. In people with depression, activity in this area is often disrupted.
tDCS works by applying a low-level electrical current through electrodes placed on the scalp. This gentle stimulation is thought to support healthier brain signaling and improve communication within mood-related networks. Unlike TMS, which requires clinic visits and higher-intensity magnetic pulses, tDCS can be safely administered at home when used as prescribed.
Treatment with the FL-100 typically follows a 12-week schedule. Patients complete five 30-minute sessions per week during the first three weeks, followed by a gradual reduction to two or three sessions per week for the remaining nine weeks. The device is paired with a digital app that guides users through each session and supports adherence.
Clinical Evidence Behind FDA Approval
FDA clearance was based largely on results from the Empower phase 2 clinical trial. This fully remote, randomized, double-blind, multicenter study enrolled 174 adults diagnosed with unipolar major depressive disorder. Participants were required to have moderate to severe symptoms, defined by a Hamilton Depression Rating Scale score of 16 or higher.
After 10 weeks of treatment, 58 percent of patients receiving active stimulation achieved remission. Secondary outcomes showed improvements on both the Hamilton and Montgomery-Asberg Depression Rating Scales, including higher response and remission rates compared to control conditions.
In addition to clinical trial data, real-world use supported the device’s effectiveness. Flow Neuroscience reported that more than 55,000 patients globally have used the device, with many experiencing symptom improvement within the first few weeks of treatment.
Safety, Eligibility, And Practical Considerations
The FL-100 device is approved for adults aged 18 and older with moderate to severe major depressive disorder who are not considered medication resistant. It may be used alone or alongside antidepressants and psychotherapy, provided those treatments are stable.
Side effects are generally mild and temporary. The most commonly reported effects include scalp irritation, headache, and tingling at the electrode sites. Rare skin burns have occurred when electrode pads were reused improperly, emphasizing the importance of patient education and adherence to instructions.
Flow Neuroscience plans to launch the device in the United States in the second quarter of 2026 as a prescription-only treatment. The estimated retail price is expected to range from $500 to $800, with insurance coverage details anticipated in early 2026.
What This Means For Interventional Psychiatry
The approval of an at-home brain stimulation device represents a meaningful shift in how neuromodulation may be delivered in the future. For clinicians, researchers, and patients, at-home brain stimulation for depression offers a new option that increases accessibility while maintaining a brain-based treatment approach.
As additional studies emerge and real-world data continue to grow, home-based neuromodulation may become an important component of stepped care models and personalized depression treatment strategies.
Citations
- Reuters coverage of FDA approval
Choudry K. U.S. FDA approves first at-home device for depression. Reuters. December 11, 2025.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-at-home-device-depression-2025-12-11/ - FDA Summary of Safety and Effectiveness Data (SSED) for FL-100
U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Flow FL-100 Cranial Electrotherapy Stimulator.
https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230024B.pdf